MAUDE Adverse Event Report: CENTINEL SPINE, LLC PRODISC L INFERIOR END PLATE MEDIUM 0-STERILE; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDL-M-IP00S
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, a surgeon implanted the patient with two prodisc l devices.At two weeks post-op, the patient was experiencing radicular symptoms and pain.It was found that one level had subsided and one level had migrated.At follow up, patient is asymptomatic and no additional surgical or medical intervention has been planned.
Additional Manufacturer Narrative
An mdr is indicated for this complaint.On (b)(6) 2023, the surgeon implanted the patient with two prodisc l devices.At two weeks post-op the patient was experiencing radicular symptoms and pain.It was found that one level had subsided and one level had migrated.At follow up, patient is asymptomatic and no additional surgical or medical intervention has been planned.A review of the dhrs found no anomalies associated with the complaint.Complaint trending found that the rate of complaints is within the levels defined in the risk documentation.A review of the risk documentation found that the risks associated with the complaint are identified and mitigated to a level where the clinical benefits outweigh the risks.Device evaluation could not be completed as the pdl device remains implanted within the patient.No anomalies were identified during the complaint investigation.The cause for the implant migration and subsidence is unknown.The submission is 6 of 6 devices involved in this event.

• Brand Name: PRODISC L INFERIOR END PLATE MEDIUM 0-STERILE
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC; 900 airport road, suite 3b; west chester PA 19380
• Manufacturer (Section G): FRUH VERPACKUNGSTECHNIK AG; allmendstrasse 47; fehraltorf, 8320 ; SZ 8320
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 18713749
• Report Number: 3007494564-2024-00017
• Device Sequence Number: 17719380
• Product Code: MJO
• UDI-Device Identifier: 00843193111753
• UDI-Public: 00843193111753
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P050010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PDL-M-IP00S
• Device Catalogue Number: N/A
• Device Lot Number: 2021-1812
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Sex: Female